Reported May 13, 2015 · Terminated

Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening…

Fujifilm Medical Systems U.S.A., Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 419 West Ave · Stamford, CT · 06902-6343

Is this the product you have?

  • Aspire HD, Full Field Digital, System, x-Ray, Mammographic
  • ModelFOR MS-1000. A mammography system used for screening and diagnosis of breast cancer
Lot codes and dates
  • Serial Number26320119
Amount recalled
1 unit

Where it was sold

Why it was recalled

User Manual lacks a description for handling some errors even though the system can be recovered from such errors

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 20, 2015 · Data as of Sep 19, 5:26 PM UTC

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